Dental FluorosisNCT05204277
Clinical Evaluation of Dental Fluororsis Treatment Modalities
A study testing Opalescence™ boost™ PF 40%, Opalustre™ and MI-Paste Plus® in people with Dental Fluorosis, run by Suez Canal University at 1 site in Egypt.
Trial summary
Background: Various treatment modalities are available to improve esthetics of fluorosed teeth based on its severity. Aim: evaluate the clinical performance of different minimal invasive treatment protocols on mild to moderate fluorosed teeth. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fluorosis
- What is being tested?
- Opalescence™ boost™ PF 40%, Opalustre™ and MI-Paste Plus®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Sep 2019to 24 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each participant had at least 8 teeth with mild to moderate dental fluorosis score 1-4 according to Thylstrup and Fejerskov index.
- Participants of age range 20-35 years old
- Good oral and general health
- Had no caries or restorations on the teeth to be treated
- Ability to return for periodic recalls
Who cannot join
- Hypersensitive teeth
- Any fixed orthodontic appliance
- Current or previous use of bleaching agents
- A history of allergies to tooth whitening product
- Smoking habits
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using an Intra-oral Spectrophotometer
Background: Various treatment modalities are available to improve esthetics of fluorosed teeth based on its severity.
Aim: evaluate the clinical performance of different minimal invasive treatment protocols on mild to moderate fluorosed teeth.
Read more
Materials and Methods: Participants were randomly allocated in eight treatment protocols with twenty teeth (n=20) included in each protocol. (P1) Opalescence boost PF 40%. (P2) Opalustre. (P3) MI-Paste Plus. In (P4) teeth were treated with Opalustre + Opalescence boost PF 40%. In (P5) Opalescence boost PF 40% + MI-Paste Plus, while in (P6) Opalustre +MI-Paste Plus. Whereas (P7) Opalustre + Opalescence boost PF 40% + MI-Paste Plus. (P8) control. All teeth were evaluated for color change (∆E) immediately after treatment (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4).
Statistical analysis: Two-way ANOVA was applied to test the interaction between different variables. ANOVA repeated measures were followed by Duncan multiple range tests (DMRTs) to compare between groups.
Read the detailed description
This study was conducted for clinical evaluation of the quality of different minimal-invasive treatment modalities and combination treatments in esthetics improvement of mild to moderate fluorosed teeth using two different evaluation methods.
Materials and Methods:
Materials used in this study were Opalustre™ (microabrasion paste of 6.6% hydrochloric acid and Silicon Carbide), Opalescence™ Boost™ PF 40% (in-office bleaching of 40% hydrogen peroxide) and MI-Paste Plus® (topical remineralizing tooth crème of casein phosphopeptide amorphous calcium fluoride phosphate).
One hundred and sixty fluorosed teeth were included in this study. Prior to the interventions, tooth color coordinates were clinically recorded by VITA Easyshade V based on CIE Lab color system as baseline records. After that teeth were randomly allocated in eight treatment protocols with twenty teeth (n=20) included in each protocol. Protocol one (P1) Opalescence™ boost™ PF 40%. Protocol two (P2) Opalustre™. Protocol three (P3) MI-Paste Plus®. In protocol four (P4) teeth were treated with Opalustre™ followed by Opalescence™ boost™ PF 40%. In protocol five (P5) Opalescence™ boost™ PF 40% was applied followed by MI-Paste Plus®, while in protocol six (P6) Opalustre™ was applied followed by MI-Paste Plus®. Whereas protocol seven (P7) teeth were treated with Opalustre™ followed by Opalescence™ boost™ PF 40% and lastly MI-Paste Plus®. Protocol eight (P8) control.
All teeth were evaluated immediately after treatment (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4). Color change was calculated from the formula ∆E=√((∆〖L)〗^2+(∆〖a)〗^2+〖(∆b)〗^2 ) , where ∆L, ∆a and ∆b were the difference between readings mean values at different evaluating times from the baseline readings. Photographs were taken; immediately after application (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4).
Data were collected, checked, revised and organized in tables and figures using Microsoft Excel 2016. Data were checked for normality using Kolmogorov-Smirnov at 0.05. ∆L, ∆a, ∆b, and ∆E were normally distributed (p>0.05) i.e. parametric data, two-way ANOVA was applied to test the interaction between different variables. ANOVA repeated measures were followed by Duncan multiple range tests (DMRTs) to compare between groups.
- Conditions
- Dental Fluorosis
- Being tested
- Opalescence™ boost™ PF 40%, Opalustre™, MI-Paste Plus®
- Keywords
- Bleaching, microabrasion, CPP-ACFP, color change, ∆E
- Medical subject headings
- Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opalescence™ boost™ PF 40%Other
40% hydrogen peroxide in-office bleaching
Opalustre™Other
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste
MI-Paste Plus®Other
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème
| Study group | Role | What they receive |
|---|---|---|
| In-office bleaching | Active comparator | 40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA) Receives: Other: Opalescence™ boost™ PF 40% |
| microabrasion | Active comparator | 6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA) Receives: Other: Opalustre™ |
| Remineralization | Active comparator | casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA). Receives: Other: MI-Paste Plus® |
| Microabrasion + In-office bleaching | Active comparator | teeth were treated with enamel microabrasion followed by in-office bleaching. Receives: Other: Opalescence™ boost™ PF 40%; Other: Opalustre™ |
| In-office bleaching + Remineralization | Active comparator | In-office bleaching was applied followed by MI-Paste Plus® Receives: Other: Opalescence™ boost™ PF 40%; Other: MI-Paste Plus® |
| Microabrasion + Remineralization | Active comparator | microabrasion was applied followed by MI-Paste Plus® Receives: Other: Opalustre™; Other: MI-Paste Plus® |
| Microabrasion + In-office bleaching + Remineralization | Active comparator | teeth were treated with microabrasion followed by inoffice bleaching and lastly MI-Paste Plus® Receives: Other: Opalescence™ boost™ PF 40%; Other: Opalustre™; Other: MI-Paste Plus® |
| Control | No intervention | no treatment (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change (∆E)
The color measurement was carried out 3 consecutive times with the same evaluator. At each time the obtained values were converted to the corresponding L, a and b values provided by the manufacturer and the mean of three measurements was taken. Color change was calculated from the formula ∆E=√((∆〖L)〗^2+(∆〖a)〗^2+〖(∆b)〗^2 ) ,
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start8 Sep 2019
- Primary completion6 May 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental FluorosisStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Nasser Abdelmoniem Youssef, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204277
- Sponsor's protocol ID
- #202/2019
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using an Intra-oral Spectrophotometer
- ClinicalTrials.gov ID
- NCT05204277
- Acronym / sponsor ID
- #202/2019
- Conditions
- Dental Fluorosis
- Keywords
- Bleaching, microabrasion, CPP-ACFP, color change, ∆E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Various treatment modalities are available to improve esthetics of fluorosed teeth based on its severity.
Aim: evaluate the clinical performance of different minimal invasive treatment protocols on mild to moderate fluorosed teeth.
Materials and Methods: Participants were randomly allocated in eight treatment protocols with twenty teeth (n=20) included in each protocol. (P1) Opalescence boost PF 40%. (P2) Opalustre. (P3) MI-Paste Plus. In (P4) teeth were treated with Opalustre + Opalescence boost PF 40%. In (P5) Opalescence boost PF 40% + MI-Paste Plus, while in (P6) Opalustre +MI-Paste Plus. Whereas (P7) Opalustre + Opalescence boost PF 40% + MI-Paste Plus. (P8) control. All teeth were evaluated for color change (∆E) immediately after treatment (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4).
Statistical analysis: Two-way ANOVA was applied to test the interaction between different variables. ANOVA repeated measures were followed by Duncan multiple range tests (DMRTs) to compare between groups.
Detailed description
This study was conducted for clinical evaluation of the quality of different minimal-invasive treatment modalities and combination treatments in esthetics improvement of mild to moderate fluorosed teeth using two different evaluation methods.
Materials and Methods:
Materials used in this study were Opalustre™ (microabrasion paste of 6.6% hydrochloric acid and Silicon Carbide), Opalescence™ Boost™ PF 40% (in-office bleaching of 40% hydrogen peroxide) and MI-Paste Plus® (topical remineralizing tooth crème of casein phosphopeptide amorphous calcium fluoride phosphate).
One hundred and sixty fluorosed teeth were included in this study. Prior to the interventions, tooth color coordinates were clinically recorded by VITA Easyshade V based on CIE Lab color system as baseline records. After that teeth were randomly allocated in eight treatment protocols with twenty teeth (n=20) included in each protocol. Protocol one (P1) Opalescence™ boost™ PF 40%. Protocol two (P2) Opalustre™. Protocol three (P3) MI-Paste Plus®. In protocol four (P4) teeth were treated with Opalustre™ followed by Opalescence™ boost™ PF 40%. In protocol five (P5) Opalescence™ boost™ PF 40% was applied followed by MI-Paste Plus®, while in protocol six (P6) Opalustre™ was applied followed by MI-Paste Plus®. Whereas protocol seven (P7) teeth were treated with Opalustre™ followed by Opalescence™ boost™ PF 40% and lastly MI-Paste Plus®. Protocol eight (P8) control.
All teeth were evaluated immediately after treatment (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4). Color change was calculated from the formula ∆E=√((∆〖L)〗^2+(∆〖a)〗^2+〖(∆b)〗^2 ) , where ∆L, ∆a and ∆b were the difference between readings mean values at different evaluating times from the baseline readings. Photographs were taken; immediately after application (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4).
Data were collected, checked, revised and organized in tables and figures using Microsoft Excel 2016. Data were checked for normality using Kolmogorov-Smirnov at 0.05. ∆L, ∆a, ∆b, and ∆E were normally distributed (p>0.05) i.e. parametric data, two-way ANOVA was applied to test the interaction between different variables. ANOVA repeated measures were followed by Duncan multiple range tests (DMRTs) to compare between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| In-office bleaching | Active comparator | Other: Opalescence™ boost™ PF 40%40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA) |
| microabrasion | Active comparator | Other: Opalustre™6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA) |
| Remineralization | Active comparator | Other: MI-Paste Plus®casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA). |
| Microabrasion + In-office bleaching | Active comparator | Other: Opalescence™ boost™ PF 40%, Other: Opalustre™teeth were treated with enamel microabrasion followed by in-office bleaching. |
| In-office bleaching + Remineralization | Active comparator | Other: Opalescence™ boost™ PF 40%, Other: MI-Paste Plus®In-office bleaching was applied followed by MI-Paste Plus® |
| Microabrasion + Remineralization | Active comparator | Other: Opalustre™, Other: MI-Paste Plus®microabrasion was applied followed by MI-Paste Plus® |
| Microabrasion + In-office bleaching + Remineralization | Active comparator | Other: Opalescence™ boost™ PF 40%, Other: Opalustre™, Other: MI-Paste Plus®teeth were treated with microabrasion followed by inoffice bleaching and lastly MI-Paste Plus® |
| Control | No intervention | –no treatment (control) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Each participant had at least 8 teeth with mild to moderate dental fluorosis score 1-4 according to Thylstrup and Fejerskov index.
Key exclusion criteria (6 listed)
- Hypersensitive teeth
- Any fixed orthodontic appliance
- Current or previous use of bleaching agents
- A history of allergies to tooth whitening product
- Smoking habits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opalescence™ boost™ PF 40%40% hydrogen peroxide in-office bleaching | Other | In-office bleaching, In-office bleaching + Remineralization, Microabrasion + In-office bleaching, Microabrasion + In-office bleaching + Remineralization |
| Opalustre™6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste | Other | Microabrasion + In-office bleaching, Microabrasion + In-office bleaching + Remineralization, Microabrasion + Remineralization, microabrasion |
| MI-Paste Plus®casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème | Other | In-office bleaching + Remineralization, Microabrasion + In-office bleaching + Remineralization, Microabrasion + Remineralization, Remineralization |
Primary outcome
Color change (∆E)
Time frame: Six Months
The color measurement was carried out 3 consecutive times with the same evaluator. At each time the obtained values were converted to the corresponding L, a and b values provided by the manufacturer and the mean of three measurements was taken. Color change was calculated from the formula ∆E=√((∆〖L)〗^2+(∆〖a)〗^2+〖(∆b)〗^2 ) ,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opalescence™ boost™ PF 40%, Opalustre™ and MI-Paste Plus® in people with Dental Fluorosis, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color change (∆E) (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.